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01
Human Clinical Studies

Five studies, each with its own page

The reported clinical studies available for Chyawanprāśa/Dabur Chyawanprash (DCP) comprises clinical investigations conducted in different population groups and clinical settings, including healthy adults, individuals with recurrent respiratory/allergic complaints, school-going children, and healthy individuals studied during the COVID-19 pandemic.

The clinical studies have evaluated the effects of Chyawanprāśa on parameters related to immunity, respiratory health, seasonal health complaints, quality of life, physical fitness and well-being, as well as safety and tolerability.

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Summary

Summary table for Clinical key finding around DCP

#StudyPopulationDesignAssessments / parametersKey findings
1DCP – Nasal Allergies and Viral InfectionsAdults with normal status, allergy, viral or bacterial respiratory infections; 40 subjectsOpen-label clinical study; 12 weeks; DCP 12 g twice dailyIgE, IgG, C3, C4, Hb, ESR, clinical/respiratory parameters, QoLReduction in IgE was reported in 30/40 subjects; improvements in several clinical and laboratory parameters were reported
2DCP – Seasonal AllergyAdults 15–75 years with non-specific seasonal complaintsDouble-blind, placebo-controlled clinical study as reported. 3 months for seasonal cohorts; 1 year for round-the-year cohort; DCP 12 g twice daily vs placeboSymptoms, Hb, TLC/DLC, ESR, PFTs, cortisol, IgE, C3/C4, biochemical parametersImprovement in symptoms, IgE, ESR, selected PFT parameters and plasma cortisol was reported
3DCP – Healthy ChildrenHealthy school-going children 5–12 years; 702 randomized, 627 completedTwo-arm, randomized, open-label, prospective, multicentre study. 6 months; DCP ~6 g twice daily followed by milk vs milk aloneInfection/allergy episodes, severity, duration, absenteeism, energy, fitness, strength, stamina, KIDSCREEN-27, CGI-I, safetyLower number and duration of illness episodes, lower absenteeism, and improvement in selected well-being/QoL parameters; no study-product-related AE/SAE reported
4DCP – COVID-19 PreventionHealthy individuals 5–70 years; 721 randomized, 696 efficacy-evaluableOpen-label, multicentre, randomized, comparative, prospective, interventional community study. 90 days; 12 g twice daily in ≥13 years; 6 g twice daily + milk in 5–12 years vs milk controlCOVID-19 incidence, RT-PCR/antigen testing, WHO ordinal scale, ILI, allergy-related symptoms, QoL, safetyLower observed COVID-19 positivity in the DCP group, significant QoL improvement, and favourable safety assessment; two mild AEs were considered possibly related
5DCP – Genoprotective and cytogenetic health50 bidi smoker individuals2-arm study; 2 months duration; 20 g Dabur Chyawanprash Awaleha twice daily for 2 monthsCytogenetic parameters including mitotic index (MI), chromosomal aberrations (CA), sister chromatid exchanges (SCE), and satellite associations (SA)All evaluated cytogenetic parameters showed a statistically significant decrease (p < 0.01) compared with bidi smokers without supplementation

The clinical assessment parameters reported in the available clinical literature include clinical symptoms, serum IgE, IgG, C3 and C4, respiratory performance tests, plasma cortisol, haematological parameters, infection/allergy episodes, duration and severity of illness, quality-of-life measures and adverse-event monitoring.

The clinical results summarized below are derived from the clinical studys and articles available in the public domain.

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Clinical interpretation

Across the studies

Immunity and Respiratory Health

The adult clinical studies evaluated immunological and respiratory parameters including IgE, IgG, C3, C4, ESR and pulmonary function. The clinical review specifically identifies these parameters, together with clinical symptoms, plasma cortisol and haematological parameters, as measures used in the clinical assessment of DCP.

The nasal-allergy/viral-infection study reported reductions in serum IgE and improvements in selected clinical and inflammatory parameters. The seasonal study similarly reported reductions in IgE and ESR and improvements in selected respiratory-function parameters.

Infection/Allergy-Related Health Outcomes in Children

The randomized pediatric study provides the most extensive comparative clinical dataset among the attached studies. It involved 702 randomized children and demonstrated fewer infection/allergy-related episodes, shorter illness duration and reduced school absenteeism in the CP group compared with the milk-only control group.

Quality of Life and General Well-Being

Quality-of-life assessments were incorporated in both the pediatric and COVID-era studies. The pediatric study used KIDSCREEN-27, while the COVID-era study used Q-LES-Q-SF. Improvements in selected quality-of-life domains were reported in both studies.

Genoprotective and Cytogenetic Health

A clinical intervention study in 25 male bidi smokers evaluated the potential genoprotective effect of Dabur Chyawanprash Awaleha (20 g twice daily for 2 months), with 25 matched controls. Cytogenetic parameters including mitotic index (MI), chromosomal aberrations (CA), sister chromatid exchanges (SCE), and satellite associations (SA) were assessed. Dabur Chyawanprash supplementation was associated with statistically significant reductions (p < 0.01) in the evaluated cytogenetic parameters compared with control bidi smokers. The findings were interpreted as indicating genoprotective potential against tobacco-smoke-associated cytogenetic damage. These findings relate to cytogenetic biomarkers and should not be interpreted as evidence of prevention or treatment of smoking-related disease.

Clinical interpretation

Based on a comprehensive review of clinical studies available in the public domain, Chyawanprash has demonstrated a broad clinical evidence base across several dimensions of its clinical profile, including immunity-related health, respiratory and allergy-related parameters, frequency and duration of infection/allergy-related episodes, quality of life, general well-being, physical fitness, cytogenetic/cellular protection, and safety and tolerability.

Safety

The available clinical studies incorporated safety monitoring through clinical assessment, adverse-event reporting, serious adverse-event reporting, vital signs and, in the seasonal study, laboratory/biochemical parameters.

The pediatric study reported no study-product-related AE or SAE, while the COVID-era study reported two mild events as possibly related to DCP and no product-related SAE.

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Overall Clinical Conclusion

A consistent clinical profile

The clinical evidence for Chyawanprāśa/Dabur Chyawanprash comprises studies with differing designs, populations and endpoints. The evidence includes an open-label adult respiratory/allergy study, a placebo-controlled seasonal-health study, a randomized prospective pediatric study, a multicentre randomized comparative study conducted during the COVID-19 pandemic, and a clinical intervention study evaluating cytogenetic parameters in male bidi smokers.

Across these studies, the reported findings include:

  1. Reduction in selected infection/allergy-related episodes;
  2. Reduction in duration of infection/allergy-related illness;
  3. Reduction in school absenteeism in children;
  4. Reduction in serum IgE in selected adult study populations;
  5. Improvement in selected respiratory-function parameters;
  6. Reduction in ESR in the seasonal-health study;
  7. Reduction in plasma cortisol in the seasonal-health study;
  8. Improvement in selected quality-of-life and general well-being parameters;
  9. Reduction in selected cytogenetic biomarkers against oxidative and genotoxic stress in male bidi smokers; and
  10. Generally favourable clinical safety and tolerability findings.

The overall evidence therefore supports a clinical profile of Dabur Chyawanprash associated with immune-health support, respiratory/allergy-related health, general well-being and cellular/genomic protection, within the populations and study conditions evaluated.